Prasugrel Tablets — Class II drug recall D-0839-2026
Ongoing recall by Mylan Pharmaceuticals Inc, reported 2026-09-09, distributed nationwide. Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
| Recall number | D-0839-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Pharmaceuticals Inc, Morgantown, WV, United States |
| Recall initiated | 2026-08-17 |
| Classified | 2026-09-11 |
| Reported by FDA | 2026-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 47,662 bottles |
| Reason classes | specification failure |
| NDC | 00378-5185, 00378-5185-93, 00378-5186, 00378-5186-93 |
| Lot numbers | 3225272 |
| Expiration dates | 2026-09-30 |
Product
Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
Reason for recall
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0839-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.